Metozolv ODT (metoclopramide orally disintegrating tablets) increases muscle contractions in the upper digestive tract. This speeds up the rate at which the stomach empties into the intestines.

Metozolv ODT is is a prescription medicine used in adults for 4 to 12 weeks to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief.

Metozolv ODT is also used to treat gastroparesis (slow stomach emptying) in people with diabetes, which can cause heartburn and stomach discomfort after meals.

Metozolv ODT is supplied as a tablet that melts in your mouth.

Do not use Metozolv ODT if you've ever had muscle movement problems after using metoclopramide or similar medicines, or if you've had a movement disorder called tardive dyskinesia. You also should not use this medicine if you've had stomach or intestinal problems (a blockage, bleeding, or a hole or tear), epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma).

NEVER USE METOZOLV ODT IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use can cause a serious movement disorder that may not be reversible. The longer you use metoclopramide, the more likely you are to develop this movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women).

Before you take Metozolv ODT, tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson's disease, or a history of depression.

Do not drink alcohol. It can increase some of the side effects of metoclopramide.

Stop using Metozolv ODT and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).

Take Metozolv ODT exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Use the medicine exactly as directed.

Metozolv ODT is taken for only 4 to 12 weeks.

NEVER USE METOCLOPRAMIDE IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of metoclopramide can cause a serious movement disorder that may not be reversible. The longer you use Metozolv ODT, the more likely you are to develop this movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women).

Metozolv ODT is usually taken 30 minutes before meals and at bedtime, or only with meals that usually cause heartburn. Follow your doctor's dosing instructions very carefully.

Do not use two different forms of metoclopramide (such as tablets and oral syrup) at the same time.

To take the Metozolv ODT orally disintegrating tablet:

• Leave the tablet in the sealed blister pack until you are ready to take it.

• Use dry hands to open a blister and take out a tablet. If the tablet breaks or crumbles throw it away and take a new tablet out of the blister pack.

• Put the tablet on your tongue right away. Let it melt and then swallow. You do not need water to take Metozolv ODT, however you may sip liquid if needed to help swallow the dissolved tablet.

Store at room temperature in a tightly-closed container, away from moisture and heat.

After you stop taking Metozolv ODT, you may have unpleasant withdrawal symptoms such as headache, dizziness, or nervousness.

Usual Adult Dose of Metozolv ODT for Gastroesophageal Reflux Disease:

Oral: 10 to 15 mg up to 4 times a day 30 minutes before meals and at bedtime, depending upon symptoms being treated and clinical response. Therapy should not exceed 12 weeks.

Usual Adult Dose of Metozolv ODT for Gastroparesis:

During the earliest manifestations of diabetic gastric stasis, oral administration may be initiated. If severe symptoms are present, therapy should begin with IM or IV administration for up to 10 days until symptoms subside at which time the patient can be switched to oral therapy. Since diabetic gastric stasis is often recurrent, therapy should be reinstituted at the earliest manifestation.

Oral: 10 mg 4 times daily, 30 minutes before meals and at bedtime, for 2 to 8 weeks depending on clinical response.

You should not use Metozolv ODT if you are allergic to metoclopramide, or if you have:

• tardive dyskinesia (a disorder of involuntary movements);

• stomach or intestinal problems such as a blockage, bleeding, or perforation (a hole or tear in your stomach or intestines);

• epilepsy or other seizure disorder;

• an adrenal gland tumor (pheochromocytoma); or

• if you've ever had muscle movement problems after using metoclopramide or similar medicines.

Tell your doctor if you have ever had:

• liver or kidney disease;

• problems with muscle movements;

• congestive heart failure or a heart rhythm disorder;

• high blood pressure;

• seizures;

• breast cancer;

• Parkinson's disease;

• diabetes; or

• depression or mental illness.

Tell your doctor if you are pregnant. Metoclopramide may harm an unborn baby if you use Metozolv ODT during late pregnancy.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Metozolv ODT is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include drowsiness, confusion, or uncontrolled muscle movements.

Drinking alcohol with this medicine can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction to Metozolv ODT: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking Metozolv ODT and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:

• tremors or shaking in your arms or legs;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

• confusion, depression, thoughts of suicide or hurting yourself;

• slow or jerky muscle movements, problems with balance or walking;

• mask-like appearance in your face;

• a seizure;

• anxiety, agitation, jittery feeling, trouble staying still, trouble sleeping;

• swelling, feeling short of breath, rapid weight gain; or

• severe nervous system reactionvery stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Metozolv ODT side effects may include:

• feeling restless;

• feeling drowsy or tired;

• lack of energy;

• nausea, vomiting;

• headache, confusion; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Metozolv ODT with other drugs that make you drowsy can worsen this effect. Ask your doctor before you take opioid pain medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines. Many drugs can affect Metozolv ODT, especially:

• acetaminophen (Tylenol);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• digoxin (digitalis, Lanoxin);

• glycopyrrolate (Robinul);

• insulin;

• levodopa (Larodopa, Atamet, Parcopa, Sinemet);

• mepenzolate (Cantil);

• tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

• blood pressure medications;

• bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin), or propantheline (Pro-Banthine);

• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or

• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), haloperidol (Haldol), olanzapine (Zyprexa, Symbyax), prochlorperazine (Compazine), risperidone (Risperdal), thiothixene (Navane), and others.

This list is not complete and there are many other drugs that can interact with metoclopramide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.